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Renal Safety Profile of Tenofovir DF (TDF)-containing vs. Thymidine Analog-containing Regimens Through 144 Weeks in Antiretroviral-naive Patients
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Reported by Jules Levin
IAC Aug 3-8, 2008, Mexico City
JE Gallant,1 AL Pozniak,2 E DeJesus,3 SS Chen,4 AK Cheng,4 and J Enejosa4
1Johns Hopkins Univ School of Medicine, Baltimore, MD; 2Chelsea & Westminster Hosp, London, UK; 3Orlando Immunology Center, Orlando, FL; 4Gilead Sciences, Inc., Foster City, CA
BACKGROUND
In clinical trials, TDF has not been associated with nephrotoxicity; nevertheless, several spontaneous cases of renal dysfunction associated with use of TDF have been reported, mostly in patients with underlying renal impairment, pre-existing systemic conditions, or in patients taking nephrotoxic agents. We investigated the renal safety profile of TDF in two large, long-term, randomized, prospective clinical studies 903 & 904.
AUTHOR CONCLUSIONS
This comparison of TDF-containing vs. thymidine analog-containing regimens in treatment-naive patients did not demonstrate an increased incidence of renal dysfunction associated with TDF through 144 weeks
--No significant changes in estimated GFR by either CG or MDRD were observed in TDF arm
--No patient in TDF group discontinued due to renal adverse events or laboratory abnormalities
--No patient developed Fanconi syndrome or proximal tubular dysfunction
Through 144 weeks, no clinically relevant changes in renal function were seen in black patients, patients ≥ 50 yrs old, patients with mild renal impairment or in patients taking anti-hypertensive and/or anti-diabetic medications
METHODS
We evaluated the renal parameters in antiretroviral-naive patients who initiated a TDF-containing vs a thymidine analog-containing regimen (Control) through 144 weeks in Studies 903 and 934
We explored changes from baseline in renal laboratory parameters in the following sub-populations:
--Black patients
--Patients ≥50 yrs old at baseline
--Patients with mild renal impairment at baseline
Defined as an estimated glomerular fi ltration rate (GFR) by Cockcroft-Gault (CG) of 50-80 mL/min
--Patients taking concomitant anti-hypertensive and/or anti-diabetic medications
RESULTS
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